Recall – X-ray system software may display incorrect patient image

Company: Cuattro LLC
Date of Enforcement Report: 5/20/2020
Class II

PRODUCT

CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0

Recall Number: Z-1934-2020

REASON

There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.

RECALLING FIRM/MANUFACTURER

Cuattro LLC on 10/15/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

9 units

DISTRIBUTION

US Nationwide

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